Telitacicept Significantly Improves Lupus Response Rates Above SOC Alone

Telitacicept has demonstrated markedly higher response rates compared to placebo in addition to standard therapy for people with systemic lupus erythematosus (SLE) in a phase 3 trial, although accordingly higher rates of adverse events (AEs) were also observed.

“These data support the central role of B-cells in the pathobiology of lupus. By targeting both BAFF and APRIL, it was possible to achieve excellent clinical results that suggest the effective restoration of immune balance in at least some of the patients. With this mechanism of action, telitacicept could significantly reduce the burden of lupus,” Ronald van Vollenhoven, MD, PhD, Professor of Rheumatology at Amsterdam University Medical Center, said in a statement.2 “This approach could represent an important new addition to the therapeutic landscape for lupus.”

The new findings are from a phase 3 trial conducted in China, results of which were published in New England Journal of Medicine. be held in Chicago, Illinois, on October 25 to 29. In the trial, participants with active SLE were randomly assigned 1:1 to receive telitacicept (160 mg) or placebo subcutaneously once weekly for 52 weeks, in addition to standard therapy. The trial primarily evaluated response on the modified SLE Responder Index 4 (SRI-4) at week 52. Response on the composite endpoint is defined as reduction of at least 4 points in the Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score, no new disease activity as measured on the British Isles Lupus Assessment Group index, and no worsening in the Physician’s Global Assessment score.

The trial screen 433 adults, 335 of which underwent randomization to telitacicept (n = 167) or placebo (n = 168). Investigators found that at week 52, significantly more participants receiving telitacicept (67.1%) had a modified SRI-4 response than those receiving placebo (32.7%; adjusted difference, 34.5%; 95% CI, 24.3-44.7; P <.001). Furthermore, 70.1% of the telitacicept group compared to 40.5% of the placebo group achieved a reduction of at least 4 points from baseline in the SELENA-SLEDAI score (difference, 29.6%; 95% CI, 13.1-46.1).

Investigators did observe significant differences in the safety profiles between the placebo and telitacicept groups. The telitacicept group had a higher incidence (74.9%) of AEs considered related to treatment then placebo (50%), including upper respiratory tract infections (31.7% vs. 19.0%), a reduced serum IgG level (15.6% vs. 1.2%), reduced serum IgM levels (15.0% vs. 0.6%), and injection-site reactions (12.6% vs. 0.6%).

“We are humbled by what these results represent for patients and the scientific community, and by the recognition that comes with their publication in The New England Journal of Medicine, which underscores the global acceptance of the quality and rigor of clinical research emerging from China. For the first time, a therapy in a Phase 3 trial is delivering more than double the clinical response seen with the current standard of care in lupus. These data present a compelling case for potentially broadening telitacicept’s use as a new standard of care worldwide,” Jean-Paul Kress, MD, Chief Executive Officer and Chairman of Vor Bio, added.2 “Lupus has challenged researchers and clinicians for decades. To see a dual BAFF/APRIL approach deliver this level of efficacy, durability, and consistency across multiple indications, while maintaining a favorable safety profile, affirms our belief that telitacicept has the potential to redefine how autoimmune diseases are treated.”

Vor Bio has also announced that findings from another phase 3 trial of telitacicept conducted in China, in people with primary Sjögren disease, will be presented at the upcoming American College of Rheumatology meeting in a late-breaking abstract. The meeting will be held in Chicago, Illinois, from October 25-29.3

References

1. van Vollenhoven RF, Wang L, Merrill JT, et al. A Phase 3 Trial of Telitacicept for Systemic Lupus Erythematosus. N Engl J Med. 2025;393(15):1475-1485. doi:10.1056/NEJMoa2414719

2. Vor Bio Announces Publication of China Phase 3 Study of Telitacicept in Systemic Lupus Erythematosus in The New England Journal of Medicine. News release. Vor Biopharma. October 16, 2025. https://www.globenewswire.com/news-release/2025/10/16/3167846/0/en/Vor-Bio-Announces-Publication-of-China-Phase-3-Study-of-Telitacicept-in-Systemic-Lupus-Erythematosus-in-The-New-England-Journal-of-Medicine.html

3. Telitacicept Demonstrates Clinically Meaningful and Statistically Significant Impact on ESSDAI Compared to Placebo in Late-Breaking China Phase 3 Results in Primary Sjögren’s Disease at ACR 2025. News release. Vor Biopharma. October 14, 2025. https://www.globenewswire.com/news-release/2025/10/14/3166097/0/en/Telitacicept-Demonstrates-Clinically-Meaningful-and-Statistically-Significant-Impact-on-ESSDAI-Compared-to-Placebo-in-Late-Breaking-China-Phase-3-Results-in-Primary-Sj%C3%B6gren-s-Disea.html